Zydus receives warning letter from USFDA for its Baddi site

Zydus Lifesciences has received a Warning Letter from the United States Food and Drug Administration (USFDA) relating to its formula on manufacturing facility located at Baddi, Himachal Pradesh.

The Warning Letter was issued in response to a request for records pursuant to sec on 704(a)(4) of the Federal Food, Drug, and Cosmetic Act, and does not pertain to any onsite inspection of the facility by the USFDA. The communication references technical observations regarding the use of purified talc that did not meet the current United
States Pharmacopeia (USP) requirements.

The company added that the said Warning Letter will not impact current operations and supplies from the Baddi site.

 

The Baddi manufacturing facility was last subjected to an on-site inspection by the USFDA in August 2025. Subsequent to the conclusion of the inspec on, the Company received the Establishment Inspection Report (EIR) in October 2025, with the final compliance status classified as Voluntary Ac on Indicated (VAI).

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